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Dafiro HCT (amlodipine besylate / valsartan / hydrochlorothiazide) – Labelling - C09DX01

Updated on site: 06-Oct-2017

Medication nameDafiro HCT
ATC CodeC09DX01
Substanceamlodipine besylate / valsartan / hydrochlorothiazide
ManufacturerNovartis Europharm Limited

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF UNIT PACK

1.NAME OF THE MEDICINAL PRODUCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade

2.STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.

3.LIST OF EXCIPIENTS

4.PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

56 x 1 film-coated tablet (unit dose)

90 film-coated tablets

98 film-coated tablets

98 x 1 film-coated tablet (unit dose)

280 film-coated tablets

280 x 1 film-coated tablet (unit dose)

5.METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6.SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7.OTHER SPECIAL WARNING(S), IF NECESSARY

8.EXPIRY DATE

EXP

9.SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in the original package in order to protect from moisture.

10.SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11.NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.MARKETING AUTHORISATION NUMBER(S)

EU/1/09/574/001

14 film-coated tablets

 

 

 

EU/1/09/574/002

28 film-coated tablets

 

 

 

EU/1/09/574/003

30 film-coated tablets

 

 

 

EU/1/09/574/004

56 film-coated tablets

 

 

 

EU/1/09/574/005

90 film-coated tablets

 

 

 

EU/1/09/574/006

98 film-coated tablets

 

 

 

EU/1/09/574/007

280 film-coated tablets

 

 

EU/1/09/574/008

56 x 1 film-coated tablet (unit dose)

 

EU/1/09/574/009

98 x 1 film-coated tablet (unit dose)

 

EU/1/09/574/010

280 x 1 film-coated tablet (unit dose)

13.BATCH NUMBER

Lot

14.GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15.INSTRUCTIONS ON USE

16.INFORMATION IN BRAILLE

Dafiro HCT 5 mg/160 mg/12.5 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

Component of a multipack comprising 20 cartons, each containing 14 tablets. 70 film-coated tablets

Component of a multipack comprising 4 cartons, each containing 70 tablets.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in the original package in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

 

 

 

 

 

EU/1/09/574/012

280 film-coated tablets (multipack, 20 cartons of 14 tablets)

 

 

 

EU/1/09/574/011

280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)

 

 

 

13.

BATCH NUMBER

Lot

 

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Dafiro HCT 5 mg/160 mg/12.5 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF MULTIPACK (WITH BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

280 film-coated tablets

Multipack comprising 20 cartons each containing 14 tablets. Multipack comprising 4 cartons, each containing 70 tablets.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in the original package in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

 

 

 

 

 

EU/1/09/574/012

280 film-coated tablets (multipack, 20 cartons of 14 tablets)

 

 

 

EU/1/09/574/011

280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)

 

 

 

13.

BATCH NUMBER

 

 

 

 

 

Lot

 

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Dafiro HCT 5 mg/160 mg/12.5 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Dafiro HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide

2.NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3.EXPIRY DATE

EXP

4.BATCH NUMBER

Lot

5.OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF UNIT PACK

1. NAME OF THE MEDICINAL PRODUCT

Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

56 x 1 film-coated tablet (unit dose)

90 film-coated tablets

98 film-coated tablets

98 x 1 film-coated tablet (unit dose)

280 film-coated tablets

280 x 1 film-coated tablet (unit dose)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in the original package in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/574/013

14 film-coated tablets

 

 

 

EU/1/09/574/014

28 film-coated tablets

 

 

 

EU/1/09/574/015

30 film-coated tablets

 

 

 

EU/1/09/574/016

56 film-coated tablets

 

 

 

EU/1/09/574/017

90 film-coated tablets

 

 

 

EU/1/09/574/018

98 film-coated tablets

 

 

 

EU/1/09/574/019

280 film-coated tablets

 

 

EU/1/09/574/020

56 x 1 film-coated tablet (unit dose)

 

EU/1/09/574/021

98 x 1 film-coated tablet (unit dose)

 

EU/1/09/574/022

280 x 1 film-coated tablet (unit dose)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Dafiro HCT 10 mg/160 mg/12.5 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

Component of a multipack comprising 20 cartons, each containing 14 tablets. 70 film-coated tablets

Component of a multipack comprising 4 cartons, each containing 70 tablets.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in the original package in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

 

 

 

 

 

EU/1/09/574/024

280 film-coated tablets (multipack, 20 cartons of 14 tablets)

 

 

 

EU/1/09/574/023

280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)

 

 

 

13.

BATCH NUMBER

Lot

 

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Dafiro HCT 10 mg/160 mg/12.5 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF MULTIPACK (WITH BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

280 film-coated tablets

Multipack comprising 20 cartons each containing 14 tablets. Multipack comprising 4 cartons, each containing 70 tablets.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in the original package in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

 

 

 

 

 

EU/1/09/574/024

280 film-coated tablets (multipack, 20 cartons of 14 tablets)

 

 

 

EU/1/09/574/023

280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)

 

 

 

13.

BATCH NUMBER

 

 

 

 

 

Lot

 

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Dafiro HCT 10 mg/160 mg/12.5 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Dafiro HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF UNIT PACK

1. NAME OF THE MEDICINAL PRODUCT

Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

56 x 1 film-coated tablet (unit dose)

90 film-coated tablets

98 film-coated tablets

98 x 1 film-coated tablet (unit dose)

280 film-coated tablets

280 x 1 film-coated tablet (unit dose)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in the original package in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/574/025

14 film-coated tablets

 

 

 

EU/1/09/574/026

28 film-coated tablets

 

 

 

EU/1/09/574/027

30 film-coated tablets

 

 

 

EU/1/09/574/028

56 film-coated tablets

 

 

 

EU/1/09/574/029

90 film-coated tablets

 

 

 

EU/1/09/574/030

98 film-coated tablets

 

 

 

EU/1/09/574/031

280 film-coated tablets

 

 

EU/1/09/574/032

56 x 1 film-coated tablet (unit dose)

 

EU/1/09/574/033

98 x 1 film-coated tablet (unit dose)

 

EU/1/09/574/034

280 x 1 film-coated tablet (unit dose)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Dafiro HCT 5 mg/160 mg/25 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

Component of a multipack comprising 20 cartons, each containing 14 tablets. 70 film-coated tablets

Component of a multipack comprising 4 cartons, each containing 70 tablets.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in the original package in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

 

 

 

 

 

EU/1/09/574/036

280 film-coated tablets (multipack, 20 cartons of 14 tablets)

 

 

 

EU/1/09/574/035

280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)

 

 

 

13.

BATCH NUMBER

Lot

 

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Dafiro HCT 5 mg/160 mg/25 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF MULTIPACK (WITH BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

280 film-coated tablets

Multipack comprising 20 cartons each containing 14 tablets. Multipack comprising 4 cartons, each containing 70 tablets.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in the original package in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

 

 

 

 

 

EU/1/09/574/036

280 film-coated tablets (multipack, 20 cartons of 14 tablets)

 

 

 

EU/1/09/574/035

280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)

 

 

 

13.

BATCH NUMBER

 

 

 

 

 

Lot

 

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Dafiro HCT 5 mg/160 mg/25 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Dafiro HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF UNIT PACK

1. NAME OF THE MEDICINAL PRODUCT

Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

56 x 1 film-coated tablet (unit dose)

90 film-coated tablets

98 film-coated tablets

98 x 1 film-coated tablet (unit dose)

280 film-coated tablets

280 x 1 film-coated tablet (unit dose)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in the original package in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/574/037

14 film-coated tablets

 

 

 

EU/1/09/574/038

28 film-coated tablets

 

 

 

EU/1/09/574/039

30 film-coated tablets

 

 

 

EU/1/09/574/040

56 film-coated tablets

 

 

 

EU/1/09/574/041

90 film-coated tablets

 

 

 

EU/1/09/574/042

98 film-coated tablets

 

 

 

EU/1/09/574/043

280 film-coated tablets

 

 

EU/1/09/574/044

56 x 1 film-coated tablet (unit dose)

 

EU/1/09/574/045

98 x 1 film-coated tablet (unit dose)

 

EU/1/09/574/046

280 x 1 film-coated tablet (unit dose)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Dafiro HCT 10 mg/160 mg/25 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

Component of a multipack comprising 20 cartons, each containing 14 tablets. 70 film-coated tablets

Component of a multipack comprising 4 cartons, each containing 70 tablets.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in the original package in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

 

 

 

 

 

EU/1/09/574/048

280 film-coated tablets (multipack, 20 cartons of 14 tablets)

 

 

 

EU/1/09/574/047

280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)

 

 

 

13.

BATCH NUMBER

Lot

 

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Dafiro HCT 10 mg/160 mg/25 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF MULTIPACK (WITH BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

280 film-coated tablets

Multipack comprising 20 cartons each containing 14 tablets. Multipack comprising 4 cartons, each containing 70 tablets.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in the original package in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

 

 

 

 

 

EU/1/09/574/048

280 film-coated tablets (multipack, 20 cartons of 14 tablets)

 

 

 

EU/1/09/574/047

280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)

 

 

 

13.

BATCH NUMBER

 

 

 

 

 

Lot

 

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Dafiro HCT 10 mg/160 mg/25 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Dafiro HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON OF UNIT PACK

1. NAME OF THE MEDICINAL PRODUCT

Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg amlodipine (as amlodipine besylate), 320 mg valsartan and 25 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

28 film-coated tablets

30 film-coated tablets

56 film-coated tablets

56 x 1 film-coated tablet (unit dose)

90 film-coated tablets

98 film-coated tablets

98 x 1 film-coated tablet (unit dose)

280 film-coated tablets

280 x 1 film-coated tablet (unit dose)

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in the original package in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12. MARKETING AUTHORISATION NUMBER(S)

EU/1/09/574/049

14 film-coated tablets

 

 

 

EU/1/09/574/050

28 film-coated tablets

 

 

 

EU/1/09/574/051

30 film-coated tablets

 

 

 

EU/1/09/574/052

56 film-coated tablets

 

 

 

EU/1/09/574/053

90 film-coated tablets

 

 

 

EU/1/09/574/054

98 film-coated tablets

 

 

 

EU/1/09/574/055

280 film-coated tablets

 

 

EU/1/09/574/056

56 x 1 film-coated tablet (unit dose)

 

EU/1/09/574/057

98 x 1 film-coated tablet (unit dose)

 

EU/1/09/574/058

280 x 1 film-coated tablet (unit dose)

13. BATCH NUMBER

Lot

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Dafiro HCT 10 mg/320 mg/25 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg amlodipine (as amlodipine besylate), 320 mg valsartan and 25 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

14 film-coated tablets

Component of a multipack comprising 20 cartons, each containing 14 tablets. 70 film-coated tablets

Component of a multipack comprising 4 cartons, each containing 70 tablets.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in the original package in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

 

 

 

 

 

EU/1/09/574/060

280 film-coated tablets (multipack, 20 cartons of 14 tablets)

 

 

 

EU/1/09/574/059

280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)

 

 

 

13.

BATCH NUMBER

Lot

 

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Dafiro HCT 10 mg/320 mg/25 mg

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

OUTER CARTON OF MULTIPACK (WITH BLUE BOX)

1. NAME OF THE MEDICINAL PRODUCT

Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide

2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each tablet contains 10 mg amlodipine (as amlodipine besylate), 320 mg valsartan and 25 mg hydrochlorothiazide.

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

280 film-coated tablets

Multipack comprising 20 cartons each containing 14 tablets. Multipack comprising 4 cartons, each containing 70 tablets.

5. METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use.

Oral use

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

EXP

9. SPECIAL STORAGE CONDITIONS

Do not store above 30°C.

Store in the original package in order to protect from moisture.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

Frimley Business Park

Camberley GU16 7SR

United Kingdom

12.

MARKETING AUTHORISATION NUMBER(S)

 

 

 

 

 

 

 

 

 

EU/1/09/574/060

280 film-coated tablets (multipack, 20 cartons of 14 tablets)

 

 

 

EU/1/09/574/059

280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)

 

 

 

13.

BATCH NUMBER

 

 

 

 

 

Lot

 

 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

15. INSTRUCTIONS ON USE

16. INFORMATION IN BRAILLE

Dafiro HCT 10 mg/320 mg/25 mg

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

BLISTERS

1. NAME OF THE MEDICINAL PRODUCT

Dafiro HCT 10 mg/320 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiazide

2. NAME OF THE MARKETING AUTHORISATION HOLDER

Novartis Europharm Limited

3. EXPIRY DATE

EXP

4. BATCH NUMBER

Lot

5. OTHER

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